Intraocular lens folder

ABSTRACT

An intraocular lens folder having a generally planar, open frame in the shape of a rounded &#34;A&#34; with a rimmed, open head at the top of the &#34;A.&#34; The base of the &#34;A&#34; forms a pair of opposing legs or handles that join to form a hinge at the crotch where the handles attach to the head. The hinge allows the handles to be squeezed together and yet spring apart when released. Squeezing the handles causes the top edge of the head rim to compress and move toward the hinge. The open head contains a plurality of projections terminating in open, relieved jaws into which the IOL is placed. The location of the projections is such that when the handles are squeezed together and the rim moves toward the hinge, two of the jaws move toward each other, causing the IOL to be folded in half.

This application is a continuation-in-part application of Ser. No.29/004,357, filed Feb. 2, 1993, now U.S. Pat. No. Des. 349,342.

BACKGROUND OF THE INVENTION

The present invention relates to intraocular lenses and particularly tofoldable intraocular lenses.

For many years, the predominant method of treating a diseased lens is toremove the lens and replace it with an intraocular lens ("IOL"). Twosurgical procedures are preferred for removing the diseased lens:extracapsular cataract extraction and phacoemulsification. Extracapsularcataract extraction involves removing the lens in a relatively intactcondition by use of a vectus or similar surgical instrument.Phacoemulsification involves contacting the lens with the vibratingcutting tip of an ultrasonically driven surgical handpiece to emulsifythe lens, thereby allowing the emulsified lens to be aspirated from theeye. Both surgical procedures require that the anterior lens capsule becut to allow access to the lens itself and to allow the implantation ofthe replacement lens, and because the capsule bag is used to hold orretain the IOL in place after surgery, the opening should be as small aspossible. Although extracapsular cataract extraction has been thepreferred surgical technique, phacoemulsification is becomingincreasingly popular, in part because of the relatively small (around 3millimeters) tunnel incision that is used with phacoemulsification.

A typical IOL comprises an artificial lens ("optic") and at least onesupport member ("haptic") for positioning the IOL within the capsularbag. The diameter of the optic varies depending on the design of theIOL, but an optic diameter of around 5 millimeters (nun) to 6 mm is mostcommon. When the surgical technique used is extracapsular cataractextraction, inserting the IOL through the relatively large incisionpresents no particular difficulties. However, when the surgicalprocedure used in phacoemulsification, the surgeon typically must widenthe initial 3 mm tunnel incision enough to allow the IOL to be insertedinto the capsular bag. Enlarging the incision reduces one of theadvantages of phacoemulsification because of the possibility forpostoperative complications associated with large incision ocularsurgery, including induced astigmatism. Therefore, rollable or foldableIOL's have been developed that can be inserted into the capsular bagwith minimal widening of the phacoemulsification incision.

As discussed in U.S. Pat. Nos. 4,573,998, 4,619,657, 4,834,750 and4,919,130, the entire contents of which is incorporated herein in itsentirety by reference, foldable IOL's generally are made frompolyurethane elastomers, silicone elastomers, hydrogel polymer collagencompounds or organic or synthetic gel compounds. The lens is rolled,compressed or crushed by a special syringe or forceps and placed intothe capsular bag without enlarging the incision. While these IOL's andinsertion devices work well, the insertion devices are bulky and requirepractice to master their use.

A second generation of foldable IOL's have recently been introduced thatare made from monomers derived from acrylacrylate or methacrylates and acrosslinking agent. Such monomers are described more fully in commonlyassigned U.S. Pat. No. 5,290,892, the entire contents of which isincorporated by reference. Such materials are advantageous because theyhave higher refractive indices and, hence, allow the IOL to be thinnerand fold more easily.

Prior to the present invention, to implant IOL's made from such acrylicmaterials, a special duckbill forceps with rounded jaws that will notclose together completely (so as not to press the sides of the foldedIOL together) was used. However, these forceps cannot, by themselves,fold the IOL, and the surgeon must hold the IOL with a secondneedle-nose or tying forceps while enveloping and folding the IOL withthe duckbill forceps. This technique, while reliable, requires the useof two hands and a great deal of practice to master.

One IOL folder disclosed in U.S. Pat. No. 5,100,410 uses a pair ofopposing jaws that when pressed together folds the IOL within a pair ofduckbill forceps. However, the recessed jaws of the folder disclosed inthis patent requires that the forceps be held in place on either side ofthe lens during folding operation, making it difficult for one person(such as the nurse) to fold the IOL while another person (such as thesurgeon) holds the forceps.

Another IOL folder disclosed in U.S. Pat. No. 5,139,501 uses a base witha fixed jaw and an opposing, movable jaw. The IOL is placed between thejaws and the movable jaw is pressed toward the fixed jaw, therebyfolding the soft IOL. However, this folder must be assembled fromseveral pieces, increasing its manufacturing cost.

Accordingly, a need continues to exist for an inexpensive, one-handeddevice that will fold easily a soft IOL.

BRIEF SUMMARY OF THE INVENTION

The present invention improves upon prior art IOL folders by providing aplastic single piece folder that easily and reliably folds an IOL usingonly one hand and requires little practice to use properly. The devicehas a generally planar, open frame in the shape of a rounded "A" with arimmed, open head at the top of the "A." The base of the "A" forms apair of opposing legs or handles that join to form a hinge at the crotchwhere the handles attach to the head. The hinge allows the handles to besqueezed together and yet spring apart when released. Squeezing thehandles causes the sides of the head to spread apart, thereby stretchingthe top edge of the head rim and pulling top edge downward toward thehinge. The open head contains a plurality of projections terminating inopen, relieved jaws into which the IOL is placed. The location of theprojections is such that when the handles are squeezed together and therim moves toward the hinge, two of the jaws moves toward each other,causing the IOL to be folded in half. The folded IOL can then be grabbedeasily by the insertion forceps. The folding operation is performed bythe present invention entirely by squeezing the handles together andlittle practice or dexterity is required to perfect the foldingtechnique. In addition, the folder of the present invention can also beused as a lens carrier and allows the lens to be rinsed and inspected bythe surgeon without removing the lens from the folder.

Accordingly, one objective of the present invention is to provide adevice for folding an intraocular lens.

Another objective of the present invention is to provide an intraocularlens folder that is easy to use.

Another objective of the present invention is to provide a single pieceintraocular lens folder.

Still another objective of the present invention is to provide anintraocular lens folder that is inexpensive to manufacture.

A further objective of the present invention is to provide anintraocular lens folder that does not press the sides of the folder lenstogether.

Another objective of the present invention is to provide an intraocularlens folder that requires the use of only one hand to fold the lens.

Still another objective of the present invention is to provide anintraocular lens folder that also can be used as a lens carrier.

These and other and further objectives and advantages of the presentinvention will become apparent form the detailed description, drawingsand claims that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the intraocular lensfolder of the present invention.

FIG. 2 is a top plan view of the intraocular lens folder illustrated inFIG. 1 shown in its relaxed state.

FIG. 3 is a top plan view of the intraocular lens folder similar to FIG.2 but showing the folder in its flexed and deformed state.

FIG. 4 is a cross-section view of the intraocular lens folderillustrated in FIG. 1 taken along line 4--4 in FIG. 2.

FIG. 5 is a cross-section view of the intraocular lens folderillustrated in FIG. 1 taken along line 5--5 in FIG. 3.

FIG. 6 is a top plan view of a second embodiment of the intraocular lensfolder of the present invention.

FIG. 7 is a cross-section view of the intraocular lens folderillustrated in FIG. 6 taken along line 7--7.

FIG. 8 is a top plan view of the second embodiment of the intraocularlens folder of the present invention similar to FIG. 6 but illustratingthe folder in its flexed, deformed and locked state.

DETAILED DESCRIPTION OF THE INVENTION

As can be seen in FIG. 1, lens folder 10 of the present inventiongenerally consists of frame 12 having a head 14 and handles 16. Frame 12is preferably molded in one piece from a relatively soft plastic such aspolypropylene or polyethylene. Head 14 generally is defined by adeformable, arcuate rim 18 and upper portions 20 so as to give head 14 ahalf ring-like appearance in plan view, as can best be seen in FIGS. 2and 6. Projecting into hollow center 22 of head 14 are a plurality ofopposing jaws 24, 26 and 28, jaw 24 being integrally formed in rim 18,jaws 28 being opposing and integrally formed in top portion 20 ofhandles 16 and jaw 26 being opposite jaw 24 and integrally formed inhinge 30 between handles 16. As best seen in FIGS. 1, 3, 4 and 5, jaws24 and 26 contain clamping faces 32 that are undercut or relieved andcontain a sill 34, thereby providing a stable platform for IOL 36 duringshipment and storage and ensuring that IOL 36 will consistently fold inthe correct direction. Jaw faces 32 may also contain pins 38 on eitherjaw 24 or jaw 26 that fit into holes 40 in either jaw 26 or jaw 24,respectively, when jaw 24 is forced into contact with jaw 26 ashereinafter described. Pins 38 and holes 40 ensure that jaws 24 and 26remained aligned during contact. An alternative to the use of pins 38and holes 40 includes using a tab 86 that fits into a corresponding slot88 as shown in FIGS. 6 and 7. Jaws 24, 26 and 28 may also contains holes52 that fit over pins (not shown) in an outer shipping container (notshown) and prevent folder 10 from moving within the shipping container.Jaws 28 may include a recess 42 into which haptics 44 of IOL 36 areplaced to help hold IOL 36 in place during storage, shipping andfolding.

As can best be seen in FIGS. 1, 2 and 3, upper portion 20 of handles 16merge with rim 18 at hinges 23 to form head 14. Handles 16 are connectedat hinge 30 and extend outwardly from hinge 30 at a slightly divergentangle. Handles 16 may be of any cross-sectional shape but an "T"cross-section having stiffening ribs 46 is preferred.

In use, IOL 36 is placed within head 14 so that IOL 36 rests on sills 34on jaw faces 32 and haptics 44 rest within recesses 42 on jaws 28, asillustrated in FIGS. 1 and 2. Force is applied to outer sides 48 ofhandles 16 so that handles 16 pivot toward each other about hinge 30. Asterminal ends 50 of handles 16 rotate toward each other about hinge 30,upper portions 20 of handles 16 (which are on an opposite side of hinge30 than ends 50) are drawn away from each other, as illustrated in FIG.3. Pulling upper portions 20 of handles 16 away from each other causesjaws 28 to be pulled away from each other and also increases the radiusof rim 18 at hinges 23, thereby flattening out rim 18. As rim 18 isflattened, jaw 24 is forced toward jaw 26. IOL 36, being capturedbetween jaws 24 and 26 by relieved jaw faces 32, is forced to bend orfold outwardly or away from sills 34, thereby allowing IOL 36 to beremoved easily from folder 10 in a folded configuration. To assist rim18 in bending only at hinges 23, rim 18 may be of a rectangular shape(i.e., taller than it is thick). For example, rim 18 may be 0.25 inchestall.

As best seen in FIGS. 6, 7 and 8, folder 10 may alternatively containclasp 82 that holds folder 10 with rim 18 in a flattened state untilclasp 82 is disengaged.

This description is given for purposes of illustration and explanation.It will be apparent to those skilled in the art that modifications andchanges may be made to the invention described herein without departingfrom its scope or spirit.

We claim:
 1. An intraocular lens folder, comprising:a) a first handleand a second handle, both handles having upper portions and terminalends opposite the upper portions; b) a hinge connecting the first handleto the second handle between the upper portions and the terminal ends;c) a deformable rim generally arcuate in shape extending between theupper portion of the first handle and the upper portion of the secondhandle thereby defining a half ring-like head with a hollow center; d) afirst jaw having a first jaw face projecting into the hollow center fromthe rim; e) a second jaw having a second jaw face projecting into thehollow center from the hinge generally opposite the first jaw; f) a slotformed in the first jaw open to the first jaw face; and g) a tab formedin the second jaw on the second jaw face that is received in the slot asthe first jaw face and the second jaw face are forced together.
 2. Theintraocular lens folder of claim 1 further comprising a third jaw and afourth jaw, both jaws having recesses and projecting into the hollowcenter from the upper portions of the first handle and the secondhandle, respectively.
 3. The intraocular lens folder of claim 1 whereinthe folder comprises plastic.
 4. An intraocular lens folder,comprising:a) a first handle and a second handle, both handles havingupper portions and terminal ends opposite the upper portions; b) a hingeconnecting the first handle to the second handle between the upperportions and the terminal ends; c) a deformable rim generally arcuate inshape extending between the upper portion of the first handle and theupper portion of the second handle thereby defining a half ting-likehead with a hollow center; d) a first jaw projecting into the centerfrom the rim; e) a second jaw projecting into the center from the rim;and f) a means for holding the rim in a flattened state.
 5. Theintraocular lens folder of claim 4 wherein the folder comprises plastic.6. The intraocular lens folder of claim 4 wherein the first jaw and thesecond jaw have jaw faces, the jaw face of the second jaw having a tabthat fits into a slot in the jaw face of the first jaw as the first jawface and the second jaw face are forced together.
 7. The intraocularlens folder of claim 4 wherein the means for holding the rim in aflattened state comprises a clasp affixed to the handles.
 8. Anintraocular lens folder, comprising:a) a first handle and a secondhandle, both handles having upper portions and terminal ends oppositethe upper portions; b) a hinge connecting the first handle to the secondhandle between the upper portions and the terminal ends; c) a deformablerim generally arcuate in shape extending between the upper portion ofthe first handle and the upper portion of the second handle therebydefining a half ting-like head with a hollow center; d) a first jawprojecting into the hollow center from the rim having a jaw face with atab; e) a second jaw projecting into the hollow center from the hingegenerally opposite the first jaw having a jaw face with a slot thataligns with the tab on the first jaw face; f) a third jaw having arecess and projecting into the hollow center from the upper portion ofthe first handle; g) a fourth jaw having a recess and projecting intothe hollow center from the upper portion of the second handle generallyopposite the third jaw; and h) a clasp affixed to the handles.
 9. Theintraocular lens folder of claim 8 wherein the folder comprises plastic.